On January 7, 2005 the U. S. Food and Drug Administration approved Abraxane (albumin-bound paclitaxel) for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy based on the statistically significant superior response rate from the randomized phase III trial mentioned above. The recommended dose of Abraxane is 260 mg/m² administered intravenously over 30 minutes every 3 weeks. No premedication to prevent hypersensitivity reactions is required prior to Abraxane administration.